Clinical Pharmacokinetics Study of ART-123 in Disseminated Intravascular Coagulation (DIC) Subjects With Renal Impairment

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the impact of impaired renal function on the pharmacokinetics of ART-123 in patients with Disseminated Intravascular Coagulation.

To investigate the safety of ART-123 in patients with Disseminated Intravascular Coagulation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asahi Kasei Pharma Corporation

Criteria

Inclusion Criteria:

• Japanese Association for Acute Medicine-defined DIC criteria score >= 4

• Written informed consent from patient or guardian

Exclusion Criteria:

• Patients showing intracranial, pulmonary, gastrointestinal hemorrhage

• Patients with a history of cerebrovascular disorders within the past 52 week

• Patients with a history of hypersensitivity to the ingredients of ART-123 preparations

• Pregnant women, nursing mothers or possibly pregnant women